Claudia Moreira de Brito1, Maria Edna de Melo2, Marcio C Mancini2, Marco Aurelio Santo3, Cintia Cercato4. 1. Grupo de Obesidade e Síndrome Metabólica, Hospital das Clínicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil. Electronic address: clau_mbrito@hotmail.com. 2. Grupo de Obesidade e Síndrome Metabólica, Hospital das Clínicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil; Laboratory of Carbohydrates and Raioimmunoassay, ICHC, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. 3. Unidade de Cirurgia Bariátrica e Metabólica, Hospital das Clínicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil. 4. Grupo de Obesidade e Síndrome Metabólica, Hospital das Clínicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil; Laboratory of Lipids, Universidade de São Paulo, São Paulo, Brazil.
Abstract
BACKGROUND: Most patients undergoing Roux-en-Y gastric bypass (RYGB) are women in reproductive age. It is not known if bariatric surgery affects the pharmacokinetics of oral contraceptives. OBJECTIVES: The primary objective was to evaluate ethinylestradiol (EE) and levonorgestrel (LNG) absorption in women undergoing RYGB, compared with nonoperated controls matched by age and body mass index (BMI). A secondary objective was to assess whether the time since surgery and BMI in the postoperative period influenced the absorption parameters. SETTING: University hospital, Brazil. METHODS: This study was designed to compare the maximum plasma concentration (Cmax), the time to the peak plasma level (Tmax), the area under the curve (AUC0-8 and AUC0-∞) after a single dose of a combined oral contraceptive with 0.03 mg EE and 0.15 mg LNG among 20 women after RYGB and 20 controls. Blood samples were obtained for 8 hours. RESULTS: The mean LNG AUC0-8 and LNG AUC0-∞ were higher in RYGB group (P = .048 and P = .004, respectively). We found a positive correlation for LNG AUC0-8 (P = .045) and AUC0-∞ (P = .004) and the time since surgery, and we found a negative correlation for LNG Cmax (P = .018), AUC0-8 (P = .003), and AUC0-∞ (P = .001) and BMI. CONCLUSION: No significant differences were found in oral EE pharmacokinetics. The operated group showed higher mean LNG AUC0-8 and AUC0-∞ but it was not considered clinically significant. The present study suggests that RYGB may not affect EE and LNG absorption.
BACKGROUND: Most patients undergoing Roux-en-Y gastric bypass (RYGB) are women in reproductive age. It is not known if bariatric surgery affects the pharmacokinetics of oral contraceptives. OBJECTIVES: The primary objective was to evaluate ethinylestradiol (EE) and levonorgestrel (LNG) absorption in women undergoing RYGB, compared with nonoperated controls matched by age and body mass index (BMI). A secondary objective was to assess whether the time since surgery and BMI in the postoperative period influenced the absorption parameters. SETTING: University hospital, Brazil. METHODS: This study was designed to compare the maximum plasma concentration (Cmax), the time to the peak plasma level (Tmax), the area under the curve (AUC0-8 and AUC0-∞) after a single dose of a combined oral contraceptive with 0.03 mg EE and 0.15 mg LNG among 20 women after RYGB and 20 controls. Blood samples were obtained for 8 hours. RESULTS: The mean LNG AUC0-8 and LNG AUC0-∞ were higher in RYGB group (P = .048 and P = .004, respectively). We found a positive correlation for LNG AUC0-8 (P = .045) and AUC0-∞ (P = .004) and the time since surgery, and we found a negative correlation for LNG Cmax (P = .018), AUC0-8 (P = .003), and AUC0-∞ (P = .001) and BMI. CONCLUSION: No significant differences were found in oral EE pharmacokinetics. The operated group showed higher mean LNG AUC0-8 and AUC0-∞ but it was not considered clinically significant. The present study suggests that RYGB may not affect EE and LNG absorption.
Authors: Jurjen S Kingma; Desirée M T Burgers; Valerie M Monpellier; Marinus J Wiezer; Heleen J Blussé van Oud-Alblas; Janelle D Vaughns; Catherine M T Sherwin; Catherijne A J Knibbe Journal: Br J Clin Pharmacol Date: 2021-06-03 Impact factor: 3.716